Testosterone, Metformin, or Both, for Hypogonadism in Obese Males

Condition(s) targeted: Hypogonadism; Obesity

Intervention: Placebo (Drug); Metformin (Drug); Testosterone Undecanoate (Drug); Metformin + Testosterone Undecanoate (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud

Official(s) and/or principal investigator(s):
Jose Carlos Fernandez-Garcia, MD, Principal Investigator, Affiliation: Hospital Universitario Virgen de la Victoria. Malaga

Overall contact:
Gloria Luque, Email: gloria.luque.exts@juntadeandalucia.es

The purpose of this study is to examine the effects of metformin, testosterone, or both, in males with obesity-related hypogonadism. This study will evaluate changes in insulin resistance, weight loss, body composition, testosterone levels,quality of life and erectile dysfunction. Obese men will receive diet and physical activity counselling, and be randomised to either testosterone, metformin, a combination of both or placebo

Official title: Randomized, Double-blind, Parallel, Placebo-controlled, Clinical Trial to Assess the Efficacy of Testosterone, Metformin, or Both, for the Treatment of Obesity-induced Male Hypogonadism

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Primary outcome: Change in Insulin Resistance

Secondary outcome:

Change in Body Weight

Change in Erectile Dysfunction

Change in the Aging Male Symptom (AMS) Scale

Change in the Androgen Deficiency in the Aging Male (ADAM) Questionnaire

Change in Testosterone Levels (Total and Free)

Change in Body Composition (Fat and Lean Mass)

Change in Biochemical Markers of Bone Turnover

Change in Metabolic Hormones

Minimum age: 18 Years. Maximum age: 50 Years. Gender(s): Male.

Criteria:

Inclusion Criteria:

- Men aged 18 to 50 years.

- BMI > or = 30 kg/m2.

- Total testosterone levels <2. 3 ng/ml (<8 nmol/l) or testosterone levels 2. 3-3. 49

ng/ml (8-12 nmol/l) and free testosterone levels <70 pg/ml.

- LH levels <7. 7 mIU / ml.

- No evidence of any other pituitary hormone disruption in morning blood sample (normal

concentrations of TSH, FT4, Prolactin, ACTH, cortisol and IGF-1

- Being able to provide informed consent before randomization and agree to comply with

all the procedures included in the protocol. Exclusion Criteria:

- Intolerance/allergy to metformin or testosterone undecanoate.

- Previous diagnosis of diabetes mellitus (HbA1c> 6. 5% or fasting glucose> 126 mg/dl or

glucose> 200 mg/dl after an oral glucose tolerance test)

- Treatment with oral hypoglycemic agents, insulin or GLP-1 analogs.

- Poor kidney function: serum creatinine> 2. 0 mg / dl.

- Previous history of prostate cancer or breast cancer.

- Active cancer of any kind.

- History of liver tumor or acute or chronic liver disease with impaired liver

function: total bilirubin> 2. 0 mg / dl or GOT levels three times the upper limit of normal.

- Central hypogonadism of organic cause

- Use in the past 12 months of any drug that affects the pituitary-gonadal axis.

- Use of oral testosterone, oral or transdermal within 2 weeks prior to study entry, or

any testosterone ester in the last 6 weeks or testosterone undecanoate injection in the 6 months prior to study entry.

- Uncontrolled hypertension (SBP> 160 mmHg or DBP> 100 mmHg) despite adequate

antihypertensive therapy.

- HIV infection or known active infection with HBV or HCV.

- Thrombotic or embolic disease.

- Heart disease, kidney or liver disease.

- Epilepsy or migraine not adequately controlled with treatment.

- Hematocrit> 50% in the screening.

- PSA> 4 ng / ml.

- Severe benign prostatic hypertrophy with an IPSS scale score over 19.

- Evidence of drug or alcohol abuse (> 50 g alcohol / day)

- Hematological diseases that produce increased risk of bleeding after intramuscular

injection.

- Serious underlying disease that might affect the patient's ability to participate in

the study (eg ongoing infection, gastric ulcers, active autoimmune disease).

- Reduced life expectancy (<12 months) by the presence of comorbidities or advanced

terminals.

- Participation in another clinical trial within 30 days before study entry.

- Previous diagnosis of hemochromatosis

- Treatment with phosphodiesterase-5 inhibitors: sildenafil, tadalafil or vardenafil

Gloria Luque, Email: gloria.luque.exts@juntadeandalucia.es

Hospital Uiversitario Virgen de la Victoria, Malaga 29010, Spain; Recruiting
Jose Carlos Fernandez-Garcia, MD, Phone: 951034016, Email: josecarlosfdezgarcia@hotmail.com
Jose Carlos Fernandez-Garcia, MD, Principal Investigator

Starting date: July 2013
Last updated: July 30, 2015